Numerous wound care products are available on the market, from OTC to prescription. Most of these are topical products approved as medical devices. Clinical development aims at ensuring timely wound healing and effective infection control, with some products being updated and improved upon, and others being altogether new technologies. Challenges to wound healing trials include heterogeneity of the patient population, variations in standard wound care procedures, and poorly defined wound assessment and quantifications measures.

Our team has a broad array of wound healing clinical trial experience and expertise. We have worked on everything from dressings and debridement, to infection potentiation products, to implantable devices. We have a track history of successful wound care R&D, including three product approvals and several rescue trials.

Our Experience:

• 20+ years of clinical product development
• 15+ years working on wound healing products
• 85+ wound healing clinical projects
• Product types: Drugs (NCEs, botanicals, biologics, cell therapies and gene therapies), devices and diagnostics
• Clinical trials: 56+ (Phase I-IV), 1,250+ sites, 12,250+ patients
• Proof of concept through FDA marketing approval
• Regulatory services: Multiple OCP, IND, NDA, BLA, 510(k), IDE, PMA and ANDA application submissions
• Full-scope and targeted-scope projects
• Several rescues of wound healing trials
• One 510(k) and two PMA wound healing market approvals

Therapeutic Indications:

• Burn wounds
• Chronic wounds
• Diabetic foot ulcer (DFU)
• Hypertropic scars
• Internal tissue damage repair
• Laceration wounds
• Pressure ulcers (PUs)
• Skin graft wounds (split-skin)
• Surgical wounds
• Tissue regeneration
• Venous leg ulcer (VLU)
• Wound debridement
• Wound infection

Product Types:

• Antibiotic, anti-infective and antimicrobial
• Combination biologics
• Cultured skin substitute
• Enzyme alginogel
• Membranes (bilayer and cellular)
• Micro gel (PEGylated fibrinogen)
• Nitric oxide
• Orthobiologics
• Oxygen therapy
• Peptides
• Purified hemoglobin
• SEM scanner
• siRNA
• Suture with stem cells
• Synthetic DNA oligonucleotide
• Synthetic extracellular matrix
• Topical adhesive
• Topical cream
• Umbilical cord blood (UCB) derived therapy